Sustainability Accounting Standards Board (SASB)

Sustainability Accounting Standards Board (SASB)

Established in 2011, the Sustainability Accounting Standards Board (SASB) is an independent, standards-setting organization dedicated to improving the effectiveness and comparability of corporate disclosure on material environmental, social and governance (ESG) factors.

Beginning with this report, the table below cross-references the SASB Standards for the Pharmaceuticals sector with where that information can be found in this report.

Index #

Description

Report Location/Direct Answer

ACCESS TO MEDICINES

HC0102-01

Description of initiatives to promote access to health care products in priority countries as defined by the Access to Medicine Index.

List of products listed in the FDA’s MedWatch Safety Alerts for Human Medical Products (Drugs and Therapeutic Biological Products) database, including those products with Potential Signals of Serious Risks or that have New Safety Information identified by the FDA Adverse Event Reporting System (FAERS).

We do not currently disclose this information. See link below for related information.

Description of product stewardship initiatives to promote take-back and redistribution or safe permanent disposal of unused product at the end of its lifecycle. Where applicable: (1) amount of direct funding for such initiatives and (2) amount of product (by weight) accepted for take-back, reuse, or disposal.

Discussion, by world region, of management process for ensuring quality and patient safety during clinical trials, including those conducted with third-party clinical research organizations (CROs). Description of processes for obtaining informed consent, of incentives offered to participants, and of any clinical trials terminated due to failure to follow good clinical practice standards.

Number of FDA Clinical Investigator Inspections of investigators used for clinical trials during the past year that resulted in: (1) Voluntary Action Indicated (VAI) and (2) Official Action Indicated (OAI).

Description of legal and regulatory fines and settlements associated with clinical trials in World Bank Low-income and Lower-middle-income Countries (LICs and LMICs) and UN HDI Medium-High Development Countries (MHDCs) that are not captured by the World Bank’s LIC or LMIC rankings. Dollar amount of fines and settlements and a description of corrective actions implemented in response to events.

Number of settlements of Abbreviated New Drug Application (ANDA) litigation that involved payments and/or provisions to delay bringing an authorized generic product to market for a defined time period.

We disclose all settlements of ANDAs to the U.S. Federal Trade Commission (FTC) and U.S. Department of Justice, as is required by law.

HC0102-11

Ratio of weighted average rate of net price increases (for all products) to the annual increase in the U.S. Consumer Price Index.

Description of legal and regulatory fines and settlements associated with false marketing claims, including Federal Food, Drug, and Cosmetic Act violations for off-label marketing prosecuted under the False Claims Act. Dollar amount of fines and settlements and a description of corrective actions implemented in response to events.

Description of talent recruitment and retention efforts for scientists and other research and development (R&D) personnel, such as mentorship and career development programs, leadership training, or unique incentive structures.

Description of legal and regulatory fines and settlements associated with bribery, corruption, or other unethical business practices, including violations of the Foreign Corrupt Practices Act and those associated with providing kickbacks to physicians. Dollar amount of fines and settlements and a description of corrective actions implemented in response to events.